How Track & Trace Solutions Improve Drug Safety & Prevent Counterfeiting

The pharmaceutical industry continues to grapple with one of its most persistent threats — counterfeit drugs. Counterfeit medicines still penetrate supply chains, threaten drug integrity, and place the manufacturers in compliance liabilities. Regulatory authorities around the world have reacted to this by mandating serialization and aggregation standards to achieve transparency and the traceability of the product through the supply chain.

As a pillar of pharmaceutical compliance strategies, Track & Trace (T&T) solutions have emerged as a means to satisfy rising requirements from regulators and companies in the pharma sector, allow for more operational transparency, reduce recalls and verify authenticity.

This is where Jekson Vision stands out as a partner in delivering advanced Track & Trace systems tailored for the pharmaceutical sector.

The Growing Threat of Counterfeit Drugs in Pharma Supply Chains

The World Health Organization (WHO) says that 1 in 10 medical products in low and middle-income countries is substandard or falsified. However, the impact on pharmaceutical manufacturers is far-reaching  revenue loss, brand damage, penalties, and production disruptions.

Key drivers for counterfeiting include:

• Fragmented and globalised supply chains
• Repackaging of a product into several regions and their distribution
• Unauthorised wholesalers and distributors are used
• Gaps in manual documentation and verification systems

In this case, Track & Trace technologies assist pharmaceutical companies to ensure the integrity of their supply chains with end-to-end visibility, real-time data capture and digital authentication.

Regulatory Push: Serialization and Aggregation Mandates

It has become evident to the global regulatory authorities that there must be a systemised traceability. In general, regulatory authorities have recognised the importance of traceability. Nowadays, emphasis is on serialization, aggregation and traceability from the US FDA’s Drug Supply Chain Security Act (DSCSA) to the EU Falsified Medicines Directive (FMD).

To meet these mandates, pharmaceutical companies have to employ Track & Trace systems that track unit-level product identification, hierarchical packaging relationships and real-time reporting to government portals.

The serialisations and aggregations solutions from Jekson Vision are based on high throughput and accuracy to deliver seamless integration with globally regulated systems in dynamic packaging environments.

What Are The Track & Trace Solutions?

Track & Trace in pharmaceuticals refers to a set of technologies that:

• Each saleable unit should be assigned with a unique identifier (serialization)
• Record the packaging hierarchy (aggregation)
• Keep track of the history of the movement of each product in the supply chain.

The core requisites:

• Serialization Modules: Print and verify 2D barcodes on each pack (serialization modules)
• Aggregation Systems: Link units to bundles, cases and pallets
• Data Management Software: Serialize data, store, and report
• Integration Tools: Integration Tools: Communicate with ERP, MES, and government portals

Operational Benefits Beyond Compliance

While regulatory adherence is the key reason for being, the operational benefits of a Track & Trace system are much broader. Pharmaceutical manufacturers can achieve:

1. Inventory Accuracy and Warehouse Efficiency

Better warehouse management, faster scanning during dispatch and accurate stock levels across locations can be obtained by aggregated data.

2. Recall Management

Serialized data makes targeted recalls better, faster, and more accurate. A recall can occur at a unit level rather than at a batch level.

3. Data-Driven Insights

Serialized data allows us to consider supply chain trends, production efficiency and distributor performance through analytics.

4. Market-Specific Customisation

The regulatory systems change from country to country. Modular configuration of Track & Trace systems enables pharma manufacturers to modify their systems easily to defects in the new market environment.

5. Brand Protection

Serialization and anti-counterfeits do not only protect the consumer but also protect the brand and its reputation.

Jekson Vision understands that every facility and market has unique needs. Our Track & Trace platforms are adaptive so they can provide end-to-end solutions from Level 1 (device) to Level 5 (enterprise/cloud) systems.

Overcoming Implementation Challenges

Track & Trace is a problem area in itself, and is made particularly difficult by the fact that facilities are usually spread across multiple geographies. Common concerns include:

Line Downtime During Integration:

Solution: Jakson Vision’s modular designs mean very little disruption to deployment.

System Scalability

Solution: We are future-ready with our platforms that are easy to scale up across lines and sites.

Data Integrity and Synchronisation

Solution: Our software has robust architecture, GAMP5 and 21 CFR Part 11 compliant.

Regulatory Complexity

We offer pre-configured compliance templates for multiple jurisdictions, reducing the burden on internal compliance teams.

The challenges posed by a change in technology, however, can be overcome by pharmaceutical companies by partnering with an experienced technology partner like Jekson Vision.

Innovation in Anti-Counterfeiting: What Lies Ahead?

Track & Trace systems can be effective but counterfeiters are also evolving. The next technological wave of innovation is enhanced digital security and real-time authentication.

Trends Shaping the Future:

Blockchain Integration:

With visibility and trust, tamper-proof records are shared through the supply chain stakeholders.

Mobile Verification:

Making the mobile app available to end users in the supply chain, i.e., distributors, pharmacists, etc., can verify product authenticity.

AI-Based Pattern Recognition:

Packaging anomalies can be identified by smart vision systems based on tampering or counterfeits.

Cloud-Based Traceability:

The data flows and the flow of data between systems, locations, and regulatory portals without manual reporting errors.

Why Partner with Jekson Vision?

Jekson Vision, with over two decades of experience in developing pharma-compliant solutions, is a technology partner that believes in innovation, reliability and customer support.

With Our Track & Trace solutions, you will have:

• High-speed serialization at up to 400 cartons/min
• Aggregation systems that support bundle, case and pallet levels.
• Seamless integration with ERP, MES, and regulatory portals
• Scalable architecture for future upgrades
• Turnkey project execution with comprehensive validation support

Jekson Vision makes your compliance journey easier, faster, and future-ready no matter if you are a contract manufacturer exporting to many countries or a large-scale pharma company ready to meet the DSCSA 2024 deadlines.

Conclusion

In an increasingly counterfeited world, pharmaceutical integrity is challenged by a myriad of crimes, and a policy of ‘no options’ should not be the answer for robust Track & Trace systems.

With a focus on technologies that combine intelligence and scalability both the safety and security of their brand as well as the optimization of their operations and compliance with the most demanding global compliance mandates are secured.

Jekson Vision is leading this transformation by helping pharmaceutical companies trace with precision, comply with confidence and grow with trust.